• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    20 Years: A Discussion on the Past & Future of Medical Product Outsourcing

    A Combined Effort for Drug Delivery & Combo Product Technology

    Examining Medical Packaging & Sterilization on Multiple Fronts

    Medical Molding Modernized

    Computer Concepts for Medical Device Design
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Teleflex’s Wattson temporary pacing guidewire FDA cleared

    PDC Partners with David Schnur Associates to Provide Manufacturing Solutions

    Olympus Releases Next-Gen ESG-410 Electrosurgical Generator

    NICO Corporation Touts Positive ENRICH Trial Results

    Study Reveals Graphene-Based Biosensors' Potential in Detecting Critical Biomarker
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    20 Years: A Discussion on the Past & Future of Medical Product Outsourcing

    A Combined Effort for Drug Delivery & Combo Product Technology

    Examining Medical Packaging & Sterilization on Multiple Fronts

    Medical Molding Modernized

    Computer Concepts for Medical Device Design
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Elizabeth Holmes’ Pre-Prison Public Persona

    Trending in Healthcare Dealmaking: Creativity, Diversification, and Distress

    How Human Factors Engineering Can Contribute to Medical Device Packaging

    How Companies Can Create a Unique Selling Proposition

    Updating Medical Device Software in the Field
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    JBC Technologies

    LEMO USA Inc.

    Cirtec Medical

    Fusion Biotec Inc.

    Providence Enterprise USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How the CHIPS Act and R&D Tax Credits Will Shape the Medtech Manufacturing Landscape

    Solving the Skills Gap Stalling the March of UK Life Sciences

    5 Ways to Reduce Nearshoring & Reshoring Costs Using Automation

    The Future of Hearing Aids: xMEMS Develops All-Silicon, Solid-State Micro Speaker

    Navigating Chinese Regulatory Requirements for Medical Device Localization
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    JBC Technologies

    LEMO USA Inc.

    Cirtec Medical

    Fusion Biotec Inc.

    Providence Enterprise USA Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FineHeart Successfully Implants, Removes Cardiac Device in Trial

    Study showed the device is easily removed with a beating heart 30 days after implantation without damaging the myocardium.

    Business Wire07.07.21
    FineHeart S.A. a preclinical medical device company that has developed the ICOMS FLOWMAKER, an Implantable Cardiac Output Management System designed to address the unmet need of patients suffering from severe heart failure, has announced the successful, simple, and breakthrough implantation and removal of its device in a 90-day in-vivo trial.
     
    This study confirms the ICOMS FLOWMAKER’s ability to support cardiac function without any heart alteration after being implanted for 30 days. The device's unique fixation system allows for easy removal performed on a beating heart, unchanged blood flow, and without trauma to the myocardium. The locking ring of the fixation system is intended to remain in place upon explantation, sidestepping additional cutting or grafts to the heart. Once the device was removed, a fully sealed occluder was introduced, and after 60 days, no structural, histological, or embolic tissue damage occured. This pioneering technique highlights FineHeart's technology's ability to adapt and support shorter surgical cardiac procedures for ventricular assist devices.
     
    "After demonstrating the ease of implantation of the ICOMS FLOWMAKER, we are very proud to show the ease of removal of the device 30 days after implantation, with post-op recovery in less than 48 hours, and more than 60 days totally free of cardiac assistance, without any structural damage to the heart," said Arnaud Mascarell, CEO and co-founder of FineHeart. "This operation to remove a cardiac assistance device with a beating heart is a world first. These results underpin the confidence of the medical community in our approach to treat patients suffering from severe heart failure. They will be able to avoid lengthy hospitalization that is often fraught with major complications. This achievement, allows for the use of the ICOMS FLOWMAKER either as temporary or permanent treatment depending on the severity of the pathology, paves the way for the First implantation in Human."
     
    The ICOMS FLOWMAKER is the first fully intraventricular, wireless flow accelerator that provides physiological support synchronized with the heart's natural contractions. It respects the natural blood flow and does not require aortic bypass surgery. It is the first miniaturized device—barely 10 cm in size—that is adjustable to patients' needs, like a pacemaker to treat patients with varying degrees of severity. It has no external driveline as it is recharged via a wireless transcutaneous energy transfer system (TET). The device is implanted using a minimally invasive beating-heart procedure, commonly performed by cardiac surgeons, and lasts on average 90 minutes.
     
    FineHeart demonstrates that the protocol for implanting and removing the ICOMS FLOWMAKER resolves the severe complications associated with implantation of left ventricle assist device (LVAD) surgery, which deteriorates the fragile cardiovascular condition of the patients treated. Today, within two years of the implantation of a classic LVAD, 80 percent of patients develop a severe complication that makes them dependent on their assistance device.

    "The ability to implant with minimally invasive surgery and subsequently explant the ICOMS FLOWMAKER paves the way for progress in facilitating hemodynamic ventricular unloading and consequent myocardial recovery. Once clinically proven, this can be a potentially disruptive step forward in the treatment of advanced heart failure," said Harvard Medical School Professor Mandeep R. Mehra, M.D., the William Harvey Distinguished Chair in Cardiovascular Medicine at Brigham and Women's Hospital, Boston, and FineHeart scientific advisory board member.
     
    Heart failure (HF) is the second leading cause of death in the United States and Europe and has become a global pandemic affecting 26 million people worldwide, with a steadily rising incidence (over 1 million new cases in G8 countries). This degenerative disease is associated with a reduced quality of life, frequent, costly hospitalizations, and early mortality. Cases of severe HF require a device to improve the pumping capacity of the left ventricle. Despite the pressing need, current LVADs are bulky, which causes significant myocardial damage. They are associated with a risk of infection, bleeding, and thrombosis, which is why they are almost exclusively implanted in very severe patients with short life expectancy. In the event of a sudden attack (cardiogenic shock), it is often necessary to wait before deciding whether to implant an LVAD and force physicians to resort to temporary circulatory assist solutions. These less invasive aids are limited in time (30 days maximum) and require the patient is bedridden a large part of the time. The prospect of a single device, such as the ICOMS FLOWMAKER, that is capable of providing both temporary support (with no time limit and preserving the patient's mobility) and permanent support if the patient does not recover sufficiently from the shock, constitutes a paradigm shift in the way severe Heart Failure patients will be treated.
     
    FineHeart is a French medical device company headquartered in Bordeaux. Its patented ICOMS innovation holds the potential to treat 200,000 severe heart failure patients annually, with FineHeart initially targeting the 50,000 patients who are eligible for hemodynamic support but today are not treated by current LVADs; a $5 billion unmet market need. FineHeart was founded in 2010 by a team of internationally renowned cardiac surgeons and cardiologists, led by Stephane Garrigue, M.D., Ph.D., CSO, Philippe Ritter, M.D., MS, co-inventor of cardiac resynchronization therapy (CRT), and Mascarell. The company benefits today from 17 patent families. FineHeart is supported by major U.S. venture capital firms specializing in the cardiovascular space, prime French investors, the European Union, and Region Nouvelle Aquitaine and Region Centre. 
    Related Searches
    • Cardiovascular
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    DDL Inc. DDL Inc.
    sfm medical devices GmbH sfm medical devices GmbH
    Heraeus Medevio Heraeus Medevio
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    Turner Imaging Systems Announces International Expansion Turner Imaging Systems Announces International Expansion
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021 MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
    Boston Scientific Agrees to Acquire Devoro Medical Boston Scientific Agrees to Acquire Devoro Medical
    CE Mark Granted to Predictive Software for Kidney Allograft Survival CE Mark Granted to Predictive Software for Kidney Allograft Survival

    Related Buyers Guide Companies

    • JK Medirise-Disposable Medical Device Company

      ...
      Ketan Munjani, Marketing Manager 11.17.22

    • DDL Inc.

      DDL Inc.

      DDL has been in medical device package, product and material testing industry for almost 20 years. We strive to offer the most effective business practices while employing a staff of technical experts.
      Chris Murphy, Marketing Manager 11.11.22

    • sfm medical devices GmbH

      ...
      Albert Busch, Head of Marketing 11.11.22


    • Heraeus Medevio

      Heraeus Medevio

      Heraeus is a globally active precious metals and technology Group with firm roots in Germany, headquartered in Hanau near Frankfurt.
      Megan Erd, Global Marketing Coordinator 11.02.22

    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging

    Loading, Please Wait..

    Trending
    • Olympus To Establish Digital Excellence Centers
    • A New Approach To Post-Market Surveillance
    • Philips Names New Supervisory Board Chairman
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Labcorp's Clinical Development Spinoff To Be Called Fortrea
    Breaking News
    • Teleflex’s Wattson temporary pacing guidewire FDA cleared
    • PDC Partners with David Schnur Associates to Provide Manufacturing Solutions
    • Olympus Releases Next-Gen ESG-410 Electrosurgical Generator
    • NICO Corporation Touts Positive ENRICH Trial Results
    • Study Reveals Graphene-Based Biosensors' Potential in Detecting Critical Biomarker
    View Breaking News >
    CURRENT ISSUE

    June 2023

    • 20 Years: A Discussion on the Past & Future of Medical Product Outsourcing
    • A Combined Effort for Drug Delivery & Combo Product Technology
    • Examining Medical Packaging & Sterilization on Multiple Fronts
    • Medical Molding Modernized
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Blue Diamond, Brightseed Partner To Discover New Almond Bioactives
    GOED Publishes Report on EPA and DHA’s Impact on Brain Health
    Alkemist Labs Creates Validated Method for Plant and Fungi-Based Psychedelics
    Coatings World

    Latest Breaking News From Coatings World

    Sandrine Garnier Joins ChemQuest as a Director
    Greenbuild Announces 2023 Keynote Speaker
    PPG’s New Paint for a New Start Initiative to Beautify Schools Worldwide with Colorful Makeovers
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    PDC Partners with David Schnur Associates to Provide Manufacturing Solutions
    Olympus Releases Next-Gen ESG-410 Electrosurgical Generator
    NICO Corporation Touts Positive ENRICH Trial Results
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Qosina, Carolina Components Partner to Market Bioprocess Components
    Astellas, KateTx Enter Exclusive License Agreement to Develop KT430
    Telix Opens $21.2M European Radiopharmaceutical Production Facility
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Boots CFO Michael Snape Resigns
    Beiersdorf Shares Progress of Its Sustainability Agenda
    Estée Lauder Announces Second Edition of Beauty&You Brand Incubator Program
    Happi

    Latest Breaking News From Happi

    Covey Skincare Names New CEO
    TerraCycle and Wrinkles Schminkles Partner in new Recycling Program
    FDA Sends Warning Letter To Maker of Mr. Lulu Sunscreen Drops
    Ink World

    Latest Breaking News From Ink World

    SICPA Inaugurates Its unlimitrust Campus
    Siegwerk’s Center of Excellence in France Receives Facelift
    Epson announces MakeTheSwitch Campaign
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Gallus to celebrate 100 years, opening new Gallus Experience Center
    Mark Andy holds successful Low Migration Workshop
    Ryback & Ryback Consulting launches Machinery division
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Terra Baby Diapers, Wipes Launch in U.S. and Canada
    The Honest Company to Exit Europe, Asia
    TechnoPlants to Exhibit at ITMA
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Osso VR Launches Virtual Reality Training Program
    Catalyst OrthoScience Names Mark Quick as CFO
    European Regulators Approve Amber Implants' VCFix Spinal System Study
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Sensormatic Unveils Sensormatic Synergy Media Display
    ams OSRAM Receives the German Innovation Award
    ASSA ABLOY Receives Clearance from Mexico for HHI Acquisition

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login